Regional Kidney Paired Donor Exchange in Sensitized Patients



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:December 2013

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Prospective, Multicenter, Observational Registry Study to Determine if Enrollment in a Regional Kidney Paired Donor Exchange Program Improves the Overall Rate of Kidney Transplantation in Sensitized Patients, and Sensitized Patients Undergoing Desensitization Treatments.

This is a prospective, multi-center, observational study to determine if a combination of
desensitization and enrollment in a regional kidney paired donor (KPD) exchange program
improves the overall rate of kidney transplantation in sensitized patients.


Inclusion Criteria:

- A. Potential Recipients must meet the following inclusion criteria:

1. Willing and able to sign an informed consent form

2. Must be at least 18 years old

3. Meet all recipient selection criteria of the transplant center

4. Listed on the deceased donor kidney waiting list for renal transplant at a
participating center

5. Potential recipients must:

Group 1: have one or more medically suitable donors who are ABO incompatible or HLA
incompatible (defined as positive serologic cross-match); or

Group 2: have a medically suitable donor that is otherwise deemed incompatible due to age,
size, or other mismatch by their respective transplant center; or

Group 3: be listed on the deceased donor waiting list for ≥ one year without an
identifiable living donor and have a PRA% ≥ 60%

B. Potential Living Donors must meet the following inclusion criteria:

1. Must provide informed consent in accordance with the process outlined in the Informed
Consent Requirements Section of the KPD Program Manual of Operations

2. Must be at least 18 years old

3. Meet all living donor selection criteria of the transplant center

4. Meet the evaluation requirements set forth in the Living Donor Evaluation Section of
the KPD Program Operational Guidelines

Exclusion Criteria:

- C. Recipients

1. Do not meet selection criteria of the transplant center

2. Eligible compatible donor at the time of enrollment

3. Inactive (not eligible to receive a kidney) on the deceased donor waitlist

4. Pregnant or breast feeding

D. Donors

1. Unwilling or unable to provide informed consent

2. Have identified barriers to donation as set forth in the Living Donor Evaluation
Section of the KPD Program Manual of Operations (Appendix A)

3. Must not be currently listed as a potential living donor for any other recipient
registered in the KPD system

4. Pregnant or breast feeding
We found this trial at
2
sites
5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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